Background
Results
Methods
DUTCH CBO-PROGNOSIS SIGNATURE DISCORDANT PATIENTS (n=128)
0 20 40 60 80 NUM BE R O F P AT IE N T S
Treatment based on prognosis Signature
68 6
Treatment based on Dutch CBO 8 46 CBO low -signature poor CBO high-signature good
Results
Conclusions
Constructive Technology Assessment (CTA) is ameans to guide the controlled implementation of new developments in the society. We used CTA for a new diagnostic test in the Netherlands, the 70-gene prognosis signature (MammaPrintTM) for node- negative breast cancer1,2,3.
A multi-center, pre-post controlled prospective study from 2004-2006, using CTA. In the RASTER-study treatment advice was based on guidelines and prognosis-signature.
1. Pre-post structured surveys were conducted concerning changes in logistics and team functioning.
2. Patient centeredness was measured by questionnaires and interviews regarding knowledge, decision making and psychological impact.
3. Scenario drafting took place as a way to anticipate diffusion and possible future developments.
1. Median implementation-time was 1.2 months. Most changes were seen in pathology processes and adjuvant treatment decision. Physicians valued the addition of the 70-gene signature information as beneficial for patient management. (table 1, 2) 2. Patient data (n=77, response 78%):High risk and
discordant clinical low/poor signature patients showed significantly more negative emotions compared to low risk patients. (table 3) 3. Original scenario (2004); discussion on validity
resulted in physicians’ tendency to treat according to the highest risk. (table 4)
CTA is appropriate for the study of early implementation of this technology. Especially to research clinical effectiveness, efficiency and patient centeredness. The CTA will be continued in the MINDACT-trial; analyzing the cost-effectiveness, updated scenarios, patients’ QoL and ethical/juridical aspects.
Implementation assessment of the 70-gene prognosis signature for breast cancer diagnostics
VP Retèl1, JM Bueno-de-Mesquita2, L van ’t Veer2, MJ van de Vijver2, MJM Hummel3, SC Linn4, WH van Harten1,3
1 Department of Psychosocial Oncology and Epidemiology, Netherlands Cancer Institute, Amsterdam, the Netherlands, 2 Department of Pathology, Netherlands Cancer Institute, Amsterdam, the Netherlands. 3 School of Governance and Management, University of Twente, Enschede, the Netherlands, 4 Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
References: 1 Van ‘t Veer et al., 2004 Nature, 2 Van de Vijver et al., 2004 NEJM, 3 Bueno- de-Mesquita et al., 2007 Lancet Oncology
VPRetèl, Department of Psychosocial Oncology and Epidemiology, Netherlands Cancer Institute, v.retel@nki.nl
Table 1: Physicians’ treatment advice
Table 3: Patients’ negative affects after test results Table 4: Scenario description in Rogers’ adoption curve
2008 ASCO Annual Meeting, May 30-June 3, McCormick Place, Chicago Poster #6575
Table 2: Characteristics participating hospitals
Hospitals 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Total Inclusions/ Signatures 172/ 106 124/ 65 114/ 41 103/ 52 66/ 40 59/ 31 40/ 19 31/ 18 21/ 9 21/ 14 18/ 13 13/ 4 6/ 3 4/ 0 4/ 3 812/ 427 Duration of implementation (months) 1.2 1.7 0.4 1.1 1.1 0.3 2.3 1.4 9.4 1.5 0.9 1.6 0.7 0.2 4.3 median 1.2 (0.2-9.4) Prior tissue
handling dry dry formali
n dry dry dry dry formalin dry dry formalin dry formalin formalin formalin 6 form/ 9 dry
Pathology lab inside/outside the hospital
in in out in out in in in in in out in out out in 11 inside/ 5 outside
Participating
team members 5 5 5 6 4 6 9 10 6 5 8 7 4 7 7 median 6
(4-10)
Signature part of treatment advice?
yes yes yes yes yes yes yes yes no no no yes no no no 9 yes/ 6 no
Who decides
treatment? MDM MDM/
onc MDM/ surg onc onc MDM/
onc MDM MDM/ onc onc MDM/
onc onc onc onc surg onc 11 onc/ 2 surg/ 7 MDM
